Catalog Number

-

Brand Name

Paradigm® REAL-Time Revel™

Version/Model Number

MMT-723KNS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P980022

Product Code

MDS

Product Code Name

Sensor, glucose, invasive

Public Device Record Key

f9a8c092-eea1-48ab-a7cc-38debe06677d

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-